NCT05771961

Impact of Rotational Atherectomy on Coronary Microcirculation

Impact of Rotational Atherectomy on Coronary Microvascular Function in Patients With Stable Angina and Calcified Coronary Artery Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Lithuanian University of Health Sciences · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this observational study is to compare the impact of rotational atherectomy to conventional stenting and to investigate how it may affect coronary microcirculation in patients with calcified coronary artery lesions and stable CAD. The study's objectives are to: * investigate the impact of rotational atherectomy on the prevalence of post-percutaneuos coronary intervention coronay microvascular dysfunction; * investigate the impact of conventional stenting on the prevalence of post-percutaneuos coronary intervention coronay microvascular dysfunction; and * compare the impact of both percutaneuos coronary interventions on coronary microvascular dysfunction. Patients with calcified lesions will be enrolled prospectively and will have serial invasive and non-invasive microvascular testing prior to and after rotational atherectomy or conventional stenting.

Detailed description

Rotational atherectomy (RA) is a medical procedure used to treat patients with severe atherosclerosis, a condition that causes plaque buildup within the artery walls, resulting in narrowing of the blood vessels and decreased blood flow to the heart. RA is a technique that involves breaking up and removing plaque from the artery with a small, high-speed rotating burr. However, RA is not without risks. One of the major risks associated with RA is the potential damage to the artery wall and surrounding tissue. This can lead to complications such as bleeding, blood clots, or injury to the heart or other organs. Additionally, the high-speed rotation of the burr can generate heat, which may damage the artery wall or cause the release of harmful particles into the bloodstream. Another hypothesized risk of RA is its impact on microcirculation, which refers to the smallest blood vessels in the body. RA can cause disruption to these vessels, leading to a decrease in blood flow and potentially causing damage to tissues and organs that depend on them. The purpose of this study is to look into the effect of rotational atherectomy on coronary microcirculation.

Conditions

• Stable Angina
• Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	coronary pressure/temperature sensor-tipped guidewire	In brief, a 6-F angioplasty guiding catheter without side-holes will be used first used to engage the left main coronary artery. A pressure-temperature sensor guidewire ( PressureWire™ X Guidewire) will be used for physiology measurements including IMR measurements. Pressure measurement from the wire will be first equalized with that of the guiding catheter. Then the pressure sensor will be positioned two-thirds of the way down the LAD artery. Intracoronary nitroglycerin will be administered (100 to 200 μg). Hyperemia will be induced with adenosine intracoronary injections.
DIAGNOSTIC_TEST	Angiography-derived index of microcirculatory resistance (IMRangio)	Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-05-01
• Completion: 2025-05-01
• First posted: 2023-03-16
• Last updated: 2023-11-13

Locations

1 site across 1 country: Lithuania